PRIMARY OBJECTIVE: To evaluate the in-vivo efficacy and safety of a skin care formulation in terms of improvement in hydration, reduction in acne, improvement in skin texture (i.e., softness & smoothness), skin firmness & elasticity, reduction in pore size, reduction in sebum content on healthy male & female subjects.SECONDARY OBJECTIVE: To evaluate the in-vivo efficacy of a skin care formulation in terms of reduction in transepidermal water loss, balancing skin pH and improvement in skin plumpness on healthy male & female subjects.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- improvement in
研究概览
简要总结
Objective:
PRIMARYOBJECTIVE To evaluate the in-vivo efficacy and safety of a skin careformulation in terms of improvement in hydration, reduction in acne,improvement in skin texture (i.e., softness & smoothness), skin firmness& elasticity, reduction in pore size, reduction in sebum content on healthymale & female subjects. • SECONDARY OBJECTIVE To evaluate the in-vivo efficacyof a skin care formulation in terms of reduction in transepidermal water loss,balancing skin pH and improvement in skin plumpness on healthy male &female subjects.
Durationof study: 28 days study
Kinetics:Screening, T0, T+10 minutes after Product application and T+28 days
Population:36 (18 Females & 18 Males) volunteers
Theevaluation is performed using:
1 Subject’s Self Evaluation
2 Dermatological Evaluation: Cosmetic Acceptability
3 Dermatological Evaluation: Efficacy
4 Corneometry
5 Cutometry
6 Sebumetry
7 Tewametry
8 Skin pH metry
9 Illustrative Images of the whole & 3/4th faceunder diffuse light
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Indian male and female subjects 2)Healthy subjects 3)Between 18 and 45 years of age.
- •Skin is healthy on the studied anatomic unit 5)Having oily & mixed oily skin and combination skin type with acne lesions, blackhead, whiteheads & visible pores.
排除标准
- •For female : Being pregnant or breastfeeding or having stopped to breastfeed in the past three months 2)Having refused to give his/her assent by signing the consent form 3)Taking part in another study liable to interfere with this study 4)In the 6 previous months Having started, changed or stopped a hormonal treatment, Having taken an oral retinoid-based treatment.
- •In the previous month Having undergone a physical or chemical treatment for acne, Having had a local benzoyl-peroxide-based treatment or a local retinoid-based treatment, Having had an oral treatment with a base of cimetidine, zinc or spironolactone 6)In the 2 previous weeks Having applied cosmetic products with anti-seborrheic aims or cosmetics for oily skin, Having had oral or local antibiotic treatment for acne, Having had beauty treatment, Having a suntanned skin on the studied areas which could interfere with the evaluations of the study 7)Refusing to follow the restrictions below during the study Do not apply cosmetic products with anti-seborrheic aims or cosmetics for oily skin , Do not have beauty treatment, Do not start, change or stop a hormonal treatment, Do not start a local or general treatment acting on seborrhoea, Do not expose himself/herself to the sun, Strictly avoid sun exposure.
结局指标
主要结局
improvement in
时间窗: BASELINE, 10 minute after Product application, 28 days
hydration, reduction in acne, improvement in skin texture (i.e., softness & smoothness), skin firmness
时间窗: BASELINE, 10 minute after Product application, 28 days
& elasticity, reduction in pore size, reduction in sebum content
时间窗: BASELINE, 10 minute after Product application, 28 days
次要结局
- reduction in transepidermal water(loss, balancing skin pH and improvement in skin plumpness)